The New Required Role of Person Responsible for Regulatory Compliance
The new medical device regulations MDR and IVDR have introduced a new role: Person Responsible for Regulatory Compliance (PRRC). According to Article 15 of MDR and IVDR, manufacturers of medical devices are now required to have a designated person who will be responsible for regulatory compliance (PRRC), ensuring that all post-market surveillance and obligations are met in accordance with Article 83. What does this mean for the manufacturers of medical devices?
At Key2Compliance, our team of experienced consultants helps manufacturers of medical devices meet the PRRC requirements and bring successful products to market. We have several consultants who act as PRRCs for various clients, ensuring compliance with MDR and IVDR regulations.
What PRRC Means for Manufacturers of Medical Devices
With the introduction of the new role of PRRC, Article 15 of the Medical Device Regulation (MDR 2017/745) states that manufacturers shall have at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.
A) A diploma, certificate, or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering, or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.
B) This requisite expertise shall be demonstrated by either evidence of formal qualification or at least four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
At GBA Key2Compliance, all our consultants acting as PRRCs fully meet these requirements, bringing extensive knowledge and expertise to help medical device companies navigate regulatory compliance.
The Role of PRRC in Regulatory Affairs and Compliance
PRRCs play a vital role in ensuring regulatory compliance throughout a product’s lifecycle. Their responsibilities typically include:
Within Regulatory Affairs:
- Ensuring the conformity of devices before release.
- Maintaining up-to-date technical documentation and EU declarations of conformity.
- Complying with post-market surveillance obligations in accordance with Article 15 of MDR 2017/745.
- Ensuring the company meets reporting obligations to authorities or notified bodies.
On the Compliance Side:
- Ensuring the manufactured product conforms to the Quality Management System.
- Overseeing the compliance and effectiveness of internal processes leading to a product.
- Verifying the applicability and current status of international standards.
- Ensuring compliance of external processes, including sourcing and external manufacturing.
A PRRC is required for every manufacturer of medical devices or in-vitro diagnostics and, in some cases, for authorized representatives and distributors as well.
Supporting Manufacturers in Meeting PRRC Requirements
Many smaller manufacturers may not fully understand the implications of the PRRC role. At GBA Key2Compliance, we help our clients determine when they need a PRRC and why it is essential. We often combine QA/RA expertise with PRRC services, providing clients with the regulatory support they need. Smaller companies have the option to subcontract a PRRC through us, ensuring they always have access to regulatory expertise without the need for a full-time in-house PRRC.
The PRRC must always be available to ensure documentation remains up to date and to address any deviations. Every quarter, the PRRC reviews relevant documentation and prepares a quarterly report, ensuring ongoing compliance.
A Simpler Way for Smaller Manufacturers to Meet Regulatory Requirements
For smaller companies, balancing regulatory compliance with cost-effective product development can be challenging. GBA Key2Compliance provides tailored solutions to help companies navigate regulations efficiently. Our expertise ensures that products meet all regulatory requirements while minimizing the risk of costly mistakes.
When working with GBA Key2Compliance, clients benefit from the collective knowledge of our entire team. While they may work closely with a dedicated consultant, they also gain access to a network of over 70 experienced professionals who collaborate to provide the best possible support. Our team continuously shares knowledge through workshops and collaboration, ensuring that our clients receive comprehensive and up-to-date regulatory guidance.
By working with GBA Key2Compliance, manufacturers can be confident that they are both compliant and set up for long-term success in the MedTech industry.